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PREMIQUE LOW DOSE 0.3MG/1.5MG MODIFIED RELEASE TABLETS

Active substance(s): CONJUGATED ESTROGENS DESSICATION WITH LACTOSE AT 4.29% CE / MEDROXYPROGESTERONE ACETATE

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Package leaflet:
Information for the patient

conjugated estrogens and
medroxyprogesterone acetate

Premique Low Dose is used for:
Relief of symptoms occurring after menopause
During the menopause, the amount of the
estrogen produced by a woman’s body drops.
This can cause symptoms such as hot face, neck
and chest ("hot flushes"). Premique Low Dose
alleviates these symptoms after menopause. You
will only be prescribed Premique Low Dose if your
symptoms seriously hinder your daily life.
You must talk to a doctor if you do not feel better
or if you feel worse.
2. What you need to know before
you take Premique Low Dose
Medical history and regular check‑ups
The use of HRT carries risks which need to be
considered when deciding whether to start taking
it, or whether to carry on taking it.

What is in this leaflet
1. What Premique Low Dose is and what it is
used for
2. What you need to know before you take
Premique Low Dose
3. How to take Premique Low Dose
4. Possible side effects
5. How to store Premique Low Dose
6. Contents of the pack and other information
1. What Premique Low Dose is and
what it is used for
Premique Low Dose is a Hormone Replacement
Therapy (HRT). It contains two types of female
hormones, an estrogen and a progestogen
(medroxyprogesterone acetate). Premique Low
Dose is used to treat some of the symptoms
and conditions associated with the menopause.
Premique Low Dose is a period-free HRT (an HRT
product where you do not have a monthly bleed).

Before you start (or restart) HRT, your doctor will
ask about your own and your family’s medical
history. Your doctor may decide to perform
a physical examination. This may include an
examination of your breasts and/or an internal
examination, if necessary.
Once you have started on Premique Low Dose
you should see your doctor for regular check‑ups
(at least once a year). At these check-ups,
discuss with your doctor the benefits and risks of
continuing with Premique Low Dose.
Go for regular breast screening, as recommended
by your doctor.

2.1 Do not take Premique Low Dose
If any of the following applies to you. If you are not
sure about any of the points below, talk to your
doctor before taking Premique Low Dose.
Do not take Premique Low Dose:
§ 
If you are allergic to conjugated estrogens
or medroxyprogesterone acetate or any of
the other ingredients of this medicine (listed in
section 6).
§ 
If you have or have ever had breast cancer, or
if you are suspected of having it.
§ 
If you have cancer which is sensitive to
estrogens, such as cancer of the womb lining
(endometrium) or if you are suspected of
having it.
§ 
If you have any unexplained vaginal bleeding.

If any of the above conditions appear for the first
time while taking Premique Low Dose, stop taking
it at once and consult your doctor immediately.
Warning and precautions
Talk to your doctor or pharmacist before taking
Premique Low Dose. Tell your doctor if you have
ever had any of the following problems, before
you start the treatment, as these may return or
become worse during treatment with Premique
Low Dose. If so, you should see your doctor more
often for check‑ups:
§ 
fibroids inside your womb
§ 
growth of womb lining outside your womb
(endometriosis) or a history of excessive growth
of the womb lining (endometrial hyperplasia)
§ 
increased risk of developing blood clots
(see section 2.3 - Blood Clots in a vein
(thrombosis) for more detail)
§ 
increased risk of getting an estrogen-sensitive
cancer (such as having a mother, sister or
grandmother who has had breast cancer) (see
section 2.2 – HRT and cancer for more detail)
§ 
high blood pressure
§ 
heart disease (see section 2.3 – Heart Disease
for more detail)
§ 
a liver disorder (e.g. a benign liver tumour)
§ 
diabetes
gallbladder disease or gallstones
§ 
§ 
migraine or severe headaches
§ 
fluid retention due to cardiac or kidney problems
§ 
a disease of the immune system that affects
many organs of the body (systemic lupus
erythematosus, SLE)
epilepsy
§ 
§ 
asthma
§ 
a disease affecting the eardrum and hearing
(otosclerosis)
§ 
low blood calcium levels (hypocalcaemia)
§ 
a very high level of fat in your blood
(triglycerides).

Stop taking Premique Low Dose and see a
doctor immediately
If you notice any of the following when taking HRT:
§ 
Any of the conditions mentioned in the ‘DO NOT
take Premique Low Dose’ section.
§ 
Yellowing of your skin or the whites of your
eyes (jaundice). These may be signs of a liver
disease.
§ 
A large rise in your blood pressure (symptoms
may be headache, tiredness, dizziness).
§ 
Migraine-like headaches which happen for the
first time.
§ 
If you become pregnant.
§ 
Have an allergic reaction, signs of which include
rash, itching, shortness of breath, difficulty
breathing and a swollen face.
If you notice signs of a blood clot, such as:
§ 
- painful swelling and redness of the legs
- sudden chest pain
- difficulty in breathing
For
 more information, see section 2.3 - Blood
Clots in a vein (thrombosis)
Note: Premique Low Dose is not a
contraceptive. If it is less than 12 months since
your last menstrual period or you are under
50 years old, you may still need to use additional
contraception to prevent pregnancy. Speak to
your doctor for advice.

Irregular bleeding
You may have irregular bleeding or drops of blood
(spotting) during the first 3‑6 months of taking
Premique Low Dose.
However, if the irregular bleeding:
§ 
carries on for more than the first 6 months
§ 
starts after you have been taking Premique Low
Dose for more than 6 months
§ 
carries on after you have stopped taking
Premique Low Dose
Ø
see your doctor as soon as possible.
Breast Cancer
Women who have breast cancer, or have had
breast cancer in the past, should not take HRT.
Evidence suggests that taking combined estrogenprogestogen and possibly also estrogen-only HRT
increases the risk of breast cancer. The extra risk
depends on how long you take HRT.
The additional risk becomes clear within a few
years. However, it returns to normal within a few
years (at most 5) after stopping treatment.
Your risk of breast cancer is also higher:
§ 
if you have a close relative (mother, sister or
grandmother) who has had breast cancer
§ 
if you are seriously overweight.

Excessive thickening of the lining of the womb
(endometrial hyperplasia) and cancer of the
lining of the womb (endometrial cancer)

Compare
Women aged 50 to 79 who are not taking HRT,
on average, 9 to 14 in 1000 will be diagnosed
with breast cancer over a 5‑year period. For
women aged 50 to 79 who are taking estrogenprogestogen HRT over 5 years, there will be 13 to
20 cases in 1000 users (i.e. an extra 4 to 6 cases).

Taking estrogen-only HRT will increase the risk
of excessive thickening of the lining of the womb
(endometrial hyperplasia) and cancer of the womb
lining (endometrial cancer). The progestogen in
Premique Low Dose protects you from this extra risk.

Regularly check your breasts. See your doctor
if you notice any changes, such as:
§ 
dimpling of the skin
§ 
changes in the nipple
§ 
any lumps you can see or feel.

If you still have your womb, your doctor may
prescribe a progestogen as well as estrogen. If
so, these may be prescribed separately, or as a
combined HRT product.

Ovarian Cancer

2.2 HRT and cancer

If you have had your womb removed (a
hysterectomy), your doctor will discuss with you
whether you can safely take estrogen without a
progestogen.
If you’ve had your womb removed because
of endometriosis, any endometrium left in
your body may be at risk. So your doctor may
prescribe HRT that includes a progestogen as
well as an estrogen.

Ovarian cancer (cancer of the ovaries) is rare much rarer than breast cancer, but it is serious.
It can be difficult to diagnose, because there are
often no obvious signs of the disease. The use of
estrogen-only or combined estrogen-progestogen
HRT has been associated with a slightly increased
risk of ovarian cancer.
The risk of ovarian cancer varies with age. For
example, in women aged 50 to 54 who are not
taking HRT, about 2 women in 2000 will be
diagnosed with ovarian cancer over a 5‑year
period. For women who have been taking HRT
for 5 years, there will be about 3 cases per 2000
users (i.e. about 1 extra case).

2.3 Effect of HRT on heart and circulation
Blood Clots in a vein (thrombosis)
The risk of blood clots in the veins (also called
deep vein thrombosis, or DVT) is about 1.3 to
3‑times higher in HRT users than in non‑users,
especially during the first year of taking it.

If you get:
§ 
a pain in your chest that spreads to your arm
or neck.
Ø

See a doctor as soon as possible and do not
take any more HRT until your doctor says you
can. This pain could be a sign of heart disease.
Stroke

Blood clots can be serious, and if one travels to
the lungs, it can cause chest pain, breathlessness,
fainting or even death. This condition is called
pulmonary embolism, or PE.

The risk of getting stroke is about 1.5 times
higher in HRT users than in non‑users. The
number of extra cases of stroke due to use of
HRT will increase with age.

DVT and PE are examples of a condition called
venous thromboembolism, or VTE.

Other things that can increase the risk of stroke
include:
getting older
§ 
§ 
high blood pressure
§ 
smoking
drinking too much alcohol
§ 
§ 
an irregular heartbeat.

You are more likely to get a blood clot in your veins
as you get older or if any of the following applies
to you. Inform your doctor if any of these situations
applies to you:
you are unable to walk for a long time because
§ 
of major surgery, injury or illness (see also
section 3, If you need to have surgery)
§ 
you are seriously overweight (BMI >30 kg/m2)
§ 
you have any blood clotting problem that needs
treatment with a medicine used to prevent blood
clots
§ 
if any of your close relatives has ever had a
blood clot in the leg, lung or another organ
§ 
you have systemic lupus erythematosus (SLE)
§ 
you have cancer
you have had a blood clot before
§ 
§ 
you are pregnant or have recently had a baby.
For signs of a blood clot, see “Stop taking
Premique Low Dose and see a doctor
immediately”.
Compare
Looking at women in their 50s who are not taking
HRT on average, over a 5‑year period, 4 to 7 in
1000 would be expected to get a blood clot in a
vein.

If you are worried about any of these things,
or if you have had a stroke in the past, talk to
your doctor to see if you should take HRT.
Compare
Looking at women in their 50s who are not taking
HRT on average 8 in 1000 would be expected to
have a stroke over a 5‑year period.

PAA079066

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
§ 
§ 
If you have further questions, ask your doctor
or pharmacist.
§ 
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
§ 
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

The experience in treating women with a
premature menopause (due to ovarian failure
or surgery) is limited. If you have a premature
menopause the risks of using HRT may be
different. Please talk to your doctor.

§ 
If you have excessive thickening of the womb
lining (endometrial hyperplasia) that is not
being treated.
If you have or have ever had a blood clot in a vein
§ 
(thrombosis), such as in the legs (deep venous
thrombosis) or the lungs (pulmonary embolism).
§ 
If you have a blood clotting disorder (such as
protein C, protein S, or antithrombin deficiency).
§ 
If you have or recently have had a disease
caused by blood clots in the arteries, such as a
heart attack, stroke or angina.
If you have or have ever had a liver disease and
§ 
your liver function tests have not returned to normal.
§ 
If you have a rare blood problem called “porphyria”
which is passed down in families (inherited).
§ 
If you are pregnant, or you are breast-feeding.

Modified Release Tablets

For women in their 50s who are taking estrogenprogestogen HRT for over 5 years, there will be
9 to 12 cases in 1000 users (i.e. an extra 5 cases).

For women in their 50s who are taking HRT, the
figure would be 11 cases in 1000 users, over
5 years (i.e. an extra 3 cases).

Heart Disease (heart attack)

If you get:
unexplained migraine-type headaches, with or
§ 
without disturbed vision

See a doctor as soon as possible and do
Ø
not take any more HRT until your doctor says
you can. These headaches may be an early
warning sign of a stroke.

HRT is not recommended for women who
have heart disease, or have had heart disease
recently. If you have ever had heart disease, talk
to your doctor to see if you should be taking HRT.
There is no evidence that HRT will prevent a heart
attack.
Women over the age of 60 who use estrogenprogestogen HRT are slightly more likely to develop
heart disease than those not taking any HRT.

/please turn over

2.4 Other conditions

2.8 Driving and using machines

HRT will not help prevent memory loss. There is
some evidence of a higher risk of memory loss in
women who start using HRT after the age of 65.
Speak to your doctor for advice.

There is no evidence to suggest that Premique
Low Dose will affect your ability to drive or to
operate machines.

Women with hypertriglyceridaemia (high levels
of fatty substances in the blood) may experience
large increases of their plasma triglycerides,
which can lead to inflammation of the pancreas
(pancreatitis). Symptoms of pancreatitis include
sudden sharp abdominal pains, abdominal
swelling, fever and feeling or being sick.
If you are taking thyroid hormone replacement
therapy (e.g. thyroxine), your doctor may monitor
your thyroid function more often when you start
treatment.

2.5 Other medicines and Premique Low Dose
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, herbal remedies or other natural
products.
Some medicines may interfere with the effect of
Premique Low Dose. This might lead to irregular
bleeding. This applies to the following medicines:
§ 
Medicines for epilepsy (such as phenobarbital,
phenytoin and carbamazepine).
§ 
Medicines for tuberculosis (such as
rifampicin, rifabutin).
§ 
Medicines for HIV infection (such as
nevirapine, efavirenz, ritonavir and nelfinavir).
§ 
Herbal remedies containing St. John’s wort
(Hypericum perforatum).
§ 
Metyrapone (most commonly used in the
treatment of Cushing’s syndrome).
Aminoglutethimide (most commonly used in
§ 
the treatment of breast cancer and Cushing’s
syndrome).

2.6 Laboratory tests
If you need a blood test, tell your doctor or the
laboratory staff that you are taking Premique
Low Dose, because this medicine can affect the
results of some tests.

2.7 Pregnancy, breast-feeding and fertility
Premique Low Dose is for use in postmenopausal
women only. If you are pregnant or breast-feeding,
think you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice
before taking this medicine.

 remique Low Dose contains lactose
2.9 P
monohydrate and sucrose
Premique Low Dose contains lactose
monohydrate and sucrose. If you have been told
by your doctor that you have an intolerance to
some sugars, contact your doctor before taking
this medicinal product.
3. How to take Premique Low Dose

3.2 If you take more Premique Low Dose than
you should

If you take too many tablets don’t worry. You may
feel some nausea (sickness), breast tenderness,
dizziness, abdominal pain, drowsiness, fatigue or
experience a short period of vaginal bleeding, but
it is unlikely that serious problems will result. If you
are concerned talk to your doctor or pharmacist.

3.3 If you forget to take Premique Low Dose
If you forget to take a tablet don’t worry. Take it as
soon as you remember and then carry on taking
the remaining tablets at the usual time.

3.1 Instructions for proper use

If more than one tablet has been forgotten, do
not take extra to try to make up for the forgotten
tablets.

Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.

Missed tablets may cause a short period of
light bleeding in women who have not had a
hysterectomy.

The recommended dose is one tablet every day.
Your doctor will aim to prescribe the lowest dose
to treat your symptom for as short as necessary.
Speak to your doctor if you think this dose is too
strong or not strong enough.
Take your tablet at the same time each day as this
will help to remind you to take your medicine.
If you are not currently taking HRT or you are taking
another period-free HRT, you may start your first
pack of Premique Low Dose at any convenient time.
If you are changing from an HRT product that gives
you a monthly bleed, start Premique Low Dose
the day after you finish the course of the previous
product, unless instructed otherwise by your doctor.
Begin your pack of Premique Low Dose by taking
the first tablet marked for that day of the week.
Continue to take one tablet each day following the
arrows until all 28 tablets have been taken.
While you are taking Premique Low Dose you will
have no tablet-free days. You should start your
next pack the day after you finish the previous one.
Premique Low Dose does not cause periods.
However, you may experience some irregular
bleeding or light bleeding (spotting) during your
first few months of taking Premique Low Dose. If
the bleeding is troublesome, or continues beyond
the first 3 months of treatment you should discuss
this with your doctor (see section titled Irregular
bleeding above).
Do not try to take off the coating, divide or crush
the tablets as this could affect the way Premique
Low Dose works.

3.4 If you need to have surgery
If you are going to have surgery make sure your
doctor knows about it and/or tell the surgeon that
you are taking Premique Low Dose. You may
need to stop taking Premique Low Dose about
4 to 6 weeks before the operation to reduce the
risk of a blood clot (see section 2.3 - Blood Clots
in a vein (thrombosis). Ask your doctor when
you can start taking Premique Low Dose again.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The following diseases are reported more often
in women using HRT compared to women not
using HRT:
• breast cancer
• abnormal growth or cancer of the lining of the
womb (endometrial hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs
(venous thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over the
age of 65.
For more information about these side effects, see
Section 2.

Other side effects
Very common: may affect more than 1 in
10 women
• breast pain
Common: may affect up to 1 in 10 women
• breakthrough

bleeding or spotting, vaginal
inflammation, period pain
• breast

tenderness, swollen breasts, nipple
discharge
• depression
• muscle

and joint aches, leg cramps
• weight

change (increase or decrease)
• changes

in your triglyceride levels (fatty
substances in the blood)
Uncommon: may affect up to 1 in 100 women

• changes
in menstrual flow, vaginal discharge
• vaginal thrush
• nausea,

bloating, abdominal pain
• headache, migraine
• blood

clots in the veins
• dizziness
in mood including anxiety
• changes

in your interest in sex (increased or
• changes

decreased libido)
• visible

swelling of the face or ankles
• itchiness, acne
• difficulty

wearing contact lenses
• gallbladder

disease (e.g. gallstones)
• hair loss
Rare: may affect up to 1 in 1,000 women
• vomiting
• changes

in breast tissue, milky secretion from
the breasts
• irritability
• allergic

reactions including swelling, rash or red
patches on the skin
• increase

in hair growth
• an
 intolerance to glucose
• a
 worsening of asthma
• increased

size of fibroids
• ovarian cancer
• worsening

of epilepsy
• heart

attack, stroke
• inflammation

of veins just under the skin
• inflammation

of the pancreas
Very rare: may affect up to 1 in 10,000 women

(e.g. yellowing of the skin)
• jaundice
• a
 worsening of chorea (an existing neurological
disorder characterised by involuntary spasmodic
movements of the body)
• a
 worsening of hypocalcaemia (low blood levels
of calcium)

vision or loss of vision
• blurred

of porphyria (a rare inherited
• worsening
metabolic disorder)
• growth

of benign liver tumours

in blood pressure.
• increase

These side effects are usually temporary and
should get better over time.
The following side effects have been reported with
other HRTs:
• various skin disorders:
○ painful reddish skin nodules (erythema
nodosum)
○ rash with target-shaped reddening or sores
(erythema multiforme)
• memory loss (dementia).
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Premique Low Dose
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
stated on the carton and blister after EXP.
The expiry date refers to the last day of that
month.
Do not store above 25°C. Keep the blister in the
outer carton to protect from light.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6.2 What Premique Low Dose looks like and
contents of the pack

Premique Low Dose 0.3 mg/1.5 mg Modified
Release Tablets are cream coloured and are
marked "PREMPRO 0.3/1.5" with black ink.
Premique Low Dose is available in packs
containing 28 or 84 tablets.
Not all pack sizes may be marketed.

6.3 Marketing Authorisation Holder and
Manufacturer

The Marketing Authorisation Holder is:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
The Manufacturer is:
Pfizer Ireland Pharmaceuticals
Little Connell
Newbridge
County Kildare
Republic of Ireland.
This leaflet was last revised in: 10/2016
* Trade mark

Ref: PQ 9_0

6. Contents of the pack and other
information

6.1 What Premique Low Dose contains

• The
active substances are conjugated
estrogens and medroxyprogesterone acetate.
Each tablet contains 0.3 mg of
conjugated estrogens and 1.5 mg of
medroxyprogesterone acetate (MPA).
• The other ingredients are lactose
monohydrate, sucrose (see section 2,
Premique contains lactose monohydrate
and sucrose), microcrystalline cellulose,
hypromellose [(2208, K100M), (2910, E6),
and (2910, E15)], magnesium stearate,
hydroxypropyl cellulose, polyethylene
glycol 400, ethyl acrylate, methacrylate,
titanium dioxide (E171), yellow iron oxide
(E172), carnauba wax and edible ink that
contains black iron oxide (E172), propylene
glycol and hypromellose.

PAA079066

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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